GUEST COLUMNISTS

• Risk Tool Selection With ICH Q9(R1) In Mind

  This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

• Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy

  If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.

• Guidelines For mRNA Drug Product Manufacturing And Quality Control

  The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.

• Emerging Market Trends For APIs

  The active pharmaceutical ingredient (API) market is estimated at $158 billion in 2023 and is projected to reach $232 billion by 2028. This article shares new market research on APIs, including an analysis of innovative and generic APIs, synthetic and biotech APIs, and more.

• Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development

  The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.

• How Strategically Partnering With Academia Supports Biotech R&D Goals

  For early-stage biotechs, partnering with leading academic institutions can help your firm cut costs and boost the returns on R&D investments while making key research and industry connections that can assist in the development, and ultimate commercialization, of your drug/therapy products.

• Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture

  Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern. 

• How To Implement Size Exclusion Chromatography And Mitigate HCP Risk

  Research shows size-exclusion chromatography improves the host cell protein detection capabilities of liquid chromatography-tandem mass spectrometry. This guest article explores the strategy of using both to better understand HCP persistence in the purification process.